Allergy Medicine | Hospira, Inc.

Ciprofloxacin should be administered intravenously at dosages described in the appropriate Dosage Guidelines tables.

2.1 Dosage in Adults

The determination of dosage and duration for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative microorganism, the integrity of the patient’s host-defense mechanisms, and the status of renal function.

Table 1: Adult Dosage Guidelines
1 Due to the designated pathogens (see Indications and Usage).2 Used in conjunction with metronidazole.3 Begin administration as soon as possible after suspected or confirmed exposure.

Infection1

Dose

Frequency

Usual Duration

Urinary Tract

200 mg to 400 mg

every 12 to every 8 hours

7 to 14 days

Lower Respiratory Tract

400 mg

every 12 to every 8 hours

7 to 14 days

Nosocomial Pneumonia

400 mg

every 8 hours

10 to 14 days

Skin and Skin Structure

400 mg

every 12 to every 8 hours

7 to 14 days

Bone and Joint

400 mg

every 12 to every 8 hours

4 to 8 weeks

Complicated Intra-Abdominal2

400 mg

every 12 hours

7 to 14 days

Acute Sinusitis

400 mg

every 12 hours

10 days

Chronic Bacterial Prostatitis

400 mg

every 12 hours

28 days

Empirical Therapy In FebrileNeutropenic Patients

Ciprofloxacin

400 mg

and

Piperacillin

50 mg/kg

every 8 hours

___________

every 4 hours

7 to 14 days

Inhalational anthrax (post-exposure)3

400 mg

every 12 hours

60 days

Plague3

400 mg

every 12 to 8 hours

14 days

Conversion of Intravenous to Oral Dosing in Adults

Patients whose therapy is started with ciprofloxacin injection may be switched to CIPRO Tablets or Oral Suspension when clinically indicated at the discretion of the physician (Table 2) [see Clinical Pharmacology (12.3)].

Table 2: Equivalent AUC Dosing Regimens

Ciprofloxacin Oral Dosage

Equivalent Ciprofloxacin Injection Dosage

250 mg Tablet every 12 hours

200 mg intravenous every 12 hours

500 mg Tablet every 12 hours

400 mg intravenous every 12 hours

750 mg Tablet every 12 hours

400 mg intravenous every 8 hours

2.2 Dosage in Pediatric Patients

Dosing and initial route of therapy (that is, IV or oral) for cUTI or pyelonephritis should be determined by the severity of the infection.

Table 3: Pediatric Dosage Guidelines
1 The total duration of therapy for cUTI and pyelonephritis in the clinical trial was determined by the physician. The mean duration of treatment was 11 days (range 10 to 21 days).2 Begin drug administration as soon as possible after suspected or confirmed exposure.3 Begin drug administration as soon as possible after suspected or confirmed exposure to Y. pestis.

Infection

Route of Administration

Dose (mg/kg)

Frequency

Total Duration

Complicated Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age)1

Intravenous

6 mg/kg to 10 mg/kg (maximum 400 mg per dose; not to be exceeded even in patients weighing >51 kg)

Every 8 hours

10 to 21 days1

Inhalational Anthrax

(Post-Exposure)2

Intravenous

10 mg/kg

(maximum 400 mg per dose)

Every 12 hours

60 days

Plague2,3

Intravenous

10 mg/kg

(maximum 400 mg per dose)

Every 12 to 8 hours

10 to 21 days

2.3 Dosage Modifications in Patients with Renal Impairment

Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. Dosage guidelines for use in patients with renal impairment are shown in Table 4.

The serum creatinine should represent a steady state of renal function.

In patients with severe infections and severe renal impairment and hepatic insufficiency, careful monitoring is suggested.

Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of cUTI and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (that is, creatinine clearance of < 50 mL/min/1.73m2).

2.4 Preparation of Ciprofloxacin for Administration

The 2 mg/mL infusion solution in 5% dextrose is available in flexible containers of 100 mL or 200 mL. The solutions in flexible containers do not need to be diluted and may be infused as described below.

If the Y-type or “piggyback” method of administration is used, it is advisable to discontinue temporarily the administration of any other solutions during the infusion of ciprofloxacin. If the concomitant use of ciprofloxacin and another drug is necessary each drug should be given separately in accordance with the recommended dosage and route of administration for each drug.

2.5 Important Administration Instructions

Intravenous Infusion

Ciprofloxacin should be administered to by intravenous infusion over a period of 60 minutes. Slow infusion of a dilute solution into a larger vein will minimize patient discomfort and reduce the risk of venous irritation.

Allergy Medicine | Sandoz Inc

Amoxicillin and clavulanate potassium for oral suspension, USP does not contain the same amount of clavulanic acid (as the potassium salt) as any of the other suspensions of amoxicillin and clavulanate potassium. Amoxicillin and clavulanate potassium for oral suspension, USP contains 42.9 mg of clavulanic acid per 5 mL, whereas the 200 mg/5 mL suspension of amoxicillin and clavulanate potassium contains 28.5 mg of clavulanic acid per 5 mL and the 400 mg/5 mL suspension contains 57 mg of clavulanic acid per 5 mL. Therefore, the 200 mg/28.5 mg per 5 mL and 400 mg/57 mg per 5 mL suspensions of amoxicillin and clavulanate potassium should notbe substituted for amoxicillin and clavulanate potassium for oral suspension, USP as they are not interchangeable.

Dosage

Pediatric Patients 3 Months and Older

Based on the amoxicillin component (600 mg per 5 mL), the recommended dose of amoxicillin and clavulanate potassium for oral suspension, USP is 90 mg/kg/day divided every 12 hours, administered for 10 days (see chart below). This dose provides 6.4 mg/kg/day of the clavulanic acid component.

Experience with amoxicillin and clavulanate potassium for oral suspension, USP in this group is not available.

Adults

Experience with amoxicillin and clavulanate potassium for oral suspension, USP in adults is not available and adults who have difficulty swallowing should not be given amoxicillin and clavulanate potassium for oral suspension, USP in place of the 500-mg or 875-mg tablet of amoxicillin and clavulanate potassium.

Prepare a suspension at time of dispensing as follows: Tap bottle until all the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see table below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.

Amoxicillin and Clavulanate Potassium for Oral Suspension

Amoxicillin and Clavulanate Potassium for Oral Suspension

Bottle Size

Amount of Water Required for Reconstitution

75 mL

62 mL

125 mL

103 mL

200 mL

165 mL

Each teaspoonful (5 mL) will contain 600 mg amoxicillin as the trihydrate and 42.9 mg of clavulanic acid as the potassium salt.

NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING.

Administration

To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium for Oral Suspension, USP should be taken at the start of a meal. Absorption of clavulanate potassium may be enhanced when Amoxicillin and Clavulanate Potassium for Oral Suspension, USP is administered at the start of a meal.